Medical implant delivery system and related methods

ABSTRACT

An example implant delivery system is disclosed. The example implant delivery system includes a delivery shaft including a proximal portion, a distal portion and a lumen extending therebetween. The delivery system also includes a frame detachably coupled to the distal portion of the delivery shaft and a tack member coupled to the frame.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication Ser. No. 62/595,737 filed on Dec. 7, 2017, the disclosure ofwhich is incorporated herein by reference.

TECHNICAL FIELD

The present disclosure pertains generally, but not by way of limitation,to orthopedic implants and methods of treatment. More particularly, thepresent disclosure relates to a tendon repair implant, such as one thatis engineered for arthroscopic placement over or in the area of a fullor partial thickness tear of the supraspinatus tendon of the shoulder.

BACKGROUND

With its complexity, range of motion and extensive use, a common softtissue injury is damage to the rotator cuff or rotator cuff tendons.Damage to the rotator cuff is a potentially serious medical conditionthat may occur during hyperextension, from an acute traumatic tear orfrom overuse of the joint. Adequate procedures do not exist forrepairing a partial thickness tear of less than 50% in the supraspinatustendon. Current procedures attempt to alleviate impingement or make roomfor movement of the tendon to prevent further damage and relievediscomfort but do not repair or strengthen the tendon. Use of the stilldamaged tendon can lead to further damage or injury. There is an ongoingneed to deliver and adequately position medical implants during anarthroscopic procedure in order to treat injuries to the rotator cuff,rotator cuff tendons, or other soft tissue or tendon injuries throughouta body.

BRIEF SUMMARY

This disclosure provides design, material, manufacturing method, and usealternatives for medical devices. An example implant delivery systemincludes a delivery shaft including a proximal portion, a distal portionand a lumen extending therebetween. The delivery system also includes aframe detachably coupled to the distal portion of the delivery shaft anda tack member coupled to the frame.

Alternatively or additionally to any of the embodiments above, whereinfurther comprising a tether member coupled to a proximal portion of thetack member.

Alternatively or additionally to any of the embodiments above, whereinthe tether member extends within the lumen of the delivery shaft.

Alternatively or additionally to any of the embodiments above, whereinthe frame includes a body portion and a plurality of attachment armsextending away from the body portion.

Alternatively or additionally to any of the embodiments above, whereinthe tack member extends through an aperture in the body portion of theframe.

Alternatively or additionally to any of the embodiments above, wherein adistal end portion of the tack member is configured to engage with abone.

Alternatively or additionally to any of the embodiments above, whereinretraction of the tether member is designed to disengage the tack memberfrom a bone.

Alternatively or additionally to any of the embodiments above, whereinthe distal end portion of the tack member includes a tapered region.

Alternatively or additionally to any of the embodiments above, wherein aproximal end portion of the tack member includes a bore extending alonga longitudinal axis of the tack member.

Alternatively or additionally to any of the embodiments above, wherein adistal end portion of the tether member is secured within the bore ofthe tack member.

Alternatively or additionally to any of the embodiments above, whereinthe plurality of attachment arms are configured to be attached to animplant.

Alternatively or additionally to any of the embodiments above, whereinthe frame is configured to detach from the delivery shaft in vivo.

Alternatively or additionally to any of the embodiments above, whereinthe tether is directly coupled to the frame.

Alternatively or additionally to any of the embodiments above, whereinthe tether is indirectly coupled to the frame via a connection member.

Alternatively or additionally to any of the embodiments above, whereinthe frame further comprises a first aperture configured to couple withthe connection member.

Alternatively or additionally to any of the embodiments above, whereinthe connection member includes a first profile and wherein the lumen ofthe delivery sheath includes a second profile, and wherein the firstprofile is configured to mate with the second profile.

Alternatively or additionally to any of the embodiments above, whereinthe connection member is configured to disengage from the deliveryshaft, and wherein the connection member is configured to remain engagedto the frame after disengaging from the delivery shaft.

Alternatively or additionally to any of the embodiments above, whereinthe tack member is stationary with respect to the connection member.

Alternatively or additionally to any of the embodiments above, whereinthe tack member can translate with respect to the connection member.

Alternatively or additionally to any of the embodiments above, whereinthe tack member includes a shaft having a circumferential surface andone or more protrusions extending radially away from the circumferentialsurface.

Alternatively or additionally to any of the embodiments above, whereinthe one or more curved protrusions are configured to anchor the tackmember beneath a layer of bone.

Alternatively or additionally to any of the embodiments above, whereinthe one or more curved protrusions are spaced away from each other alongthe shaft.

Alternatively or additionally to any of the embodiments above, whereinthe tack member includes a shaft formed from a first material and one ormore fixation members disposed along the shaft, wherein the one or morefixation members are formed from a second material different from thefirst material.

Alternatively or additionally to any of the embodiments above, whereinthe one or more fixation members extending radially away from acircumferential surface of the shaft.

Alternatively or additionally to any of the embodiments above, whereinthe tether extends within the lumen of the delivery shaft while thedelivery shaft is attached to the frame, and wherein the tether remainsconnected to the frame when the delivery shaft is detached from theframe.

An example method for delivering an implant to repair a tendon includesadvancing an implant repair system to a target site. The implant repairsystem includes a delivery shaft including a proximal portion and adistal portion, and a frame detachably coupled to the distal portion ofthe delivery shaft via a connection member. The frame includes a bodyportion and a plurality of attachment arms extending away from the bodyportion. A tack member is coupled to the connection member. An implantis attached to the attachment arms. The method further includespositioning the implant adjacent a bony structure of the target site andengaging the tack member with the bony structure. Thereafter, thedelivery shaft is detached from the frame in vivo with the tack memberremaining engaged with the bony structure. Thereafter, the implant isaffixed to the target site.

Alternatively or additionally to any of the embodiments above, whereinthe connection member is coupled between a distal end of the deliveryshaft and the frame, and wherein detaching the delivery shaft from theframe includes disengaging the connection member from the distal end ofthe delivery shaft.

Alternatively or additionally to any of the embodiments above, whereinengaging the tack member further includes anchoring the tack into thebony structure.

Alternatively or additionally to any of the embodiments above, whereinthe tack member includes a shaft having a circumferential surface andone or more curved protrusions extending radially away from thecircumferential surface, and wherein anchoring the tack into the bonystructure includes positioning the one or more curved portions beneath acortical layer of bone.

Alternatively or additionally to any of the embodiments above, whereinthe tack member includes a shaft formed from a first material and one ormore fixation members disposed along the shaft, wherein the one or morefixation members are formed from a second material different from thefirst material, and wherein anchoring the tack into the bony structureincludes positioning the one or more fixation members adjacent acortical layer of bone.

Alternatively or additionally to any of the embodiments above, whereinthe method further comprises withdrawing the frame from the target siteafter affixing the implant to the target site, and wherein withdrawingthe frame from the target site includes retracting a tether coupled tothe frame.

The above summary of some embodiments is not intended to describe eachdisclosed embodiment or every implementation of the present disclosure.The Figures, and Detailed Description, which follow, more particularlyexemplify these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure may be more completely understood in consideration of thefollowing detailed description in connection with the accompanyingdrawings, in which:

FIG. 1 illustrates a cross-section of an anterior view of a shoulder ofa patient;

FIG. 2 illustrates a shoulder including a head of the humerus matingwith the glenoid fossa of the scapula at a glenohumeral joint and animplant affixed to a tendon;

FIG. 3 illustrates an example implant delivery device attached to animplant;

FIG. 4A illustrates another example implant delivery device;

FIG. 4B illustrates another example implant delivery device;

FIG. 5A illustrates another example implant delivery device attached toan implant;

FIG. 5B illustrates an example delivery device attached to an implant;

FIG. 5C illustrates an example delivery device attached to an implant;

FIG. 6 illustrates another example implant delivery device;

FIG. 7 illustrates an example implant delivery device attached to animplant;

FIG. 8 illustrates another example implant delivery device;

FIG. 9A illustrates another example implant delivery device attached toan implant;

FIG. 9B illustrates an example delivery device attached to an implant;

FIG. 9C illustrates an example delivery device attached to an implant;

FIG. 9D illustrates an example delivery device attached to an implant;

FIG. 9E illustrates an example delivery device attached to an implant;

FIG. 10 illustrates another example implant delivery device;

FIG. 11 illustrates another example implant delivery device;

FIG. 12A illustrates a plan view of another example implant deliverydevice;

FIG. 12B illustrates an example tack member;

FIG. 12C illustrates another example tack member;

FIG. 12D illustrates another example tack member;

FIG. 12E illustrates another example tack member;

FIG. 13A illustrates a side view of another example implant deliverydevice with the sheath in cross-section;

FIG. 13B illustrates a side view of another example implant deliverydevice with the sheath in cross-section;

FIG. 13C illustrates an end view along line 13C-13-C of FIG. 13B; and

FIGS. 14-18 illustrate an exemplary method of installing an implant withan example implant delivery device at a target site.

While the disclosure is amenable to various modifications andalternative forms, specifics thereof have been shown by way of examplein the drawings and will be described in detail. It should beunderstood, however, that the intention is not to limit the disclosureto the particular embodiments described. On the contrary, the intentionis to cover all modifications, equivalents, and alternatives fallingwithin the spirit and scope of the disclosure.

DETAILED DESCRIPTION

For the following defined terms, these definitions shall be applied,unless a different definition is given in the claims or elsewhere inthis specification.

All numeric values are herein assumed to be modified by the term“about”, whether or not explicitly indicated. The term “about” generallyrefers to a range of numbers that one of skill in the art would considerequivalent to the recited value (e.g., having the same function orresult). In many instances, the terms “about” may include numbers thatare rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numberswithin that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and5).

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” include plural referents unless the contentclearly dictates otherwise. As used in this specification and theappended claims, the term “or” is generally employed in its senseincluding “and/or” unless the content clearly dictates otherwise.

It is noted that references in the specification to “an embodiment”,“some embodiments”, “other embodiments”, etc., indicate that theembodiment described may include one or more particular features,structures, and/or characteristics. However, such recitations do notnecessarily mean that all embodiments include the particular features,structures, and/or characteristics. Additionally, when particularfeatures, structures, and/or characteristics are described in connectionwith one embodiment, it should be understood that such features,structures, and/or characteristics may also be used connection withother embodiments whether or not explicitly described unless clearlystated to the contrary.

The following detailed description should be read with reference to thedrawings in which similar elements in different drawings are numberedthe same. The drawings, which are not necessarily to scale, depictillustrative embodiments and are not intended to limit the scope of thedisclosure.

With its complexity, range of motion and extensive use, a common softtissue injury is damage to the rotator cuff or rotator cuff tendons.Damage to the rotator cuff is a potentially serious medical conditionthat may occur during hyperextension, from an acute traumatic tear orfrom overuse of the joint. Current repair procedures may attempt toalleviate impingement or make room for movement of the tendon to preventfurther damage and relieve discomfort but do not repair or strengthenthe tendon. An accepted treatment for rotator cuff tears may includereattaching the torn tendon to the humeral head using sutures.Additionally, in treating rotator cuff tears, an accepted practice mayalso include the placement of a scaffold over the repaired tendon tomechanically reinforce the repaired tendon. Therefore, there is anongoing need to deliver and adequately position medical implants duringan arthroscopic procedure in order to treat injuries to the rotatorcuff, rotator cuff tendons, or other soft tissue or tendon injuriesthroughout a body.

FIG. 1 shows a cross-sectional view of a shoulder 10 including anexample implant 12. Shoulder 10 further shows a head 14 of humerus 16mating with a glenoid fossa 18 of scapula 20. The glenoid fossa 18comprises a shallow depression in scapula 20. A supraspinatus tendon 22is also shown. These muscles (along with others) control the movement ofhumerus 16 relative to scapula 20. A distal tendon 24 of supraspinatustendon 22 meets humerus 16 at an insertion point 26.

In FIG. 1, tendon 24 includes a damaged portion 28 located nearinsertion point 26. Damaged portion 28 includes a tear 30 extendingpartially through tendon 24. Tear 30 may be referred to as a partialthickness tear. The depicted partial thickness tear 30 is on the bursalside of the tendon, however, the tear may also be on the opposite orarticular side of the tendon 24 and/or may include internal tears to thetendon 24 not visible on either surface.

FIG. 1 further illustrates that the tendon repair implant 12 has beenplaced over the partial thickness tear 30. In this example, the tendonrepair implant 12 is placed on the bursal side of the tendon regardlessof whether the tear is on the bursal side, articular side or within thetendon. Further, the tendon repair implant 12 may overlay multipletears.

In some instances, delivery of an implant 12 (e.g., a sheet-likeimplant) to a target site of a patient may require a physician to createan incision in the patient sufficient to access the target implant site.After creating this “access site,” the physician may insert an implantdelivery system through the access site and position the distal end ofthe implant delivery system adjacent the target implant site. Thephysician may then manipulate the implant delivery system to deploy animplant out of a delivery sheath adjacent the target implant site.

For example, FIG. 2 provides a perspective view of an implant deliverysystem 40 extending through the shoulder 10 of a patient. FIG. 2 showsimplant delivery system 40 deployed adjacent a target site (e.g., a tearin the supraspinatus tendon). In at least some embodiments, implantdelivery system 40 comprises a sheath member 42 (e.g., a cannula)including a proximal portion (not shown), a distal portion 48 and alumen extending within at least a portion of cannula 42. Further,implant delivery system 40 may include a delivery shaft 44 extendingwithin the lumen of sheath member 42 and longitudinally movable relativethereto.

Delivery shaft 44 may include a proximal portion (not shown) extendingout of the proximal portion of sheath member 42 and/or otherwisemanipulatable relative to sheath member 42 by a user. Additionally, insome examples the proximal portion of delivery shaft 44 and/or sheathmember 44 may be coupled to a handle member (not shown). The handlemember may be utilized to manipulate delivery shaft 44. For example, thehandle member may be utilized to impart a rotational force to deliveryshaft 44.

In addition, delivery shaft 44 may include a distal portion 50 extendingout of the distal portion 48 of sheath member 42. Further, deliveryshaft 44 may include a lumen extending therein. The lumen of deliveryshaft 44 may extend along a portion or the entire length delivery shaft44 (e.g., from distal portion 50 to the proximal portion of deliveryshaft 44).

Delivery system 40 may further include a detachable frame member 46attached to the distal portion 50 of the delivery shaft 44. As shown inFIG. 2, detachable frame 46 may be attached to an implant 12 (e.g., asheet-like implant). For purposes of the discussion herein, the combinedstructure including frame 46 and implant 12 may be defined as having aproximal end 52 and a distal end 54 as illustrated in FIG. 2.

When initially positioning the frame 46 and implant 12 adjacent a targetsite, a clinician may orient the frame 46 and implant 12 (for example,via a handle member attached to a proximal portion of the delivery shaft44) such that the proximal portion 52 may be adjacent (e.g., overlaid)on a portion of the humerus (e.g., on the bone), while the distalportion 54 of the frame 46 and implant 12 may overlay the tendon 24.

As described above, delivery of implant delivery system 40 may includethe insertion of delivery sheath 42 through an access site (e.g.,incision) and advancement to a target site. After positioning the distalend 48 of delivery sheath 42 proximate the target site, a clinician maydeploy the detachable frame 46 in combination with the implant 12 out ofthe lumen located within and along the distal portion 48 of the deliverysheath 42, such as by retracting delivery sheath 42 relative to deliveryshaft 44 and frame 46, and positioning implant 12 and frame 46 over thetarget site.

Prior to deployment, the detachable frame 46 and implant 12 combinationmay be contained (e.g., housed) within the lumen of delivery sheath 42for subsequent deployment distally out distal opening of delivery sheath42. As will be described in greater detail below, the combination ofdetachable frame 46 and implant 12 may wrap and/or fold upon itself suchthat it may be positioned within the lumen of the delivery sheath 42.Alternatively, detachable frame 46 and implant 12 may warp and/or foldaround implant delivery shaft 44 while disposed within delivery sheath42. The delivery sheath 42 constrains the frame 46 in a contractedconfiguration within the lumen of the delivery sheath 42.

FIG. 3 shows an example detachable frame member 46 attached to exampleimplant 12. As stated above with reference to FIG. 2, detachable framemember 46 and implant 12 may have a proximal portion 52 which, forpurposes of discussion herein, may be adjacent delivery shaft 44 and beconfigured to be positioned adjacent humerus 16. Further, detachableframe member 46 and implant 12 may have a distal portion 54 which, forpurposes of discussion herein, may extend away from deliver shaft 44 andbe configured to be positioned adjacent tendon 24.

FIG. 3 further shows fastening regions 15 located at various positionswithin implant 12. As shown in FIG. 3, the fastening regions 15 arepositioned at locations which are free from the structure of framemember 46. In other words, the shape of frame 46 may be designed tospecifically permit fastening implant 12 to the anatomy at locations 15.For example, a clinician may staple implant 12 to the anatomy atlocations 15.

FIG. 4A shows an example detachable frame member 46. As shown in FIG.4A, frame member 46 may include a body portion 56. In some examples,body portion 56 may be understood to define a circular, ovular, orsimilar shaped framework from which other members may extend. Forexample, body portion 56 of frame 46 may bear some resemblance to anelongated oval having a proximal portion 52 and a distal portion 54.Body portion 56 may include one or more apertures 74. Further, frame 46may include a head portion 58 positioned within and/or extending awayfrom the proximal portion 52. Head portion 52 may include an aperture60.

As shown in FIG. 4A, detachable frame 46 may include one or moreattachment arms 64 extending away from body portion 56. Each respectiveattachment arm 64 may include a proximal portion 66 and a distal portion68. The proximal portion 66 of each of the attachment arms 64 may berigidly attached to body portion 56, while the distal portion 68 may bea free end of the attachment arm 64 spaced away from body portion 56. Insome examples (such as that shown in FIG. 4A), attachment arms 64 andhead portion 58 may form a monolithic structure with body portion 56. Inother words, in some examples body portion 56, head portion 58 andattachment arms 64 may be formed (e.g., machined, cut, shaped, stamped,laser-cut, etc.) as a unitary structure from a single piece of material.However, the above discussion is not intended to be limiting. Rather, itis contemplated that detachable frame 46 may be constructed usingalternative materials and/or manufacturing methodologies. For example,frame 46, or portions thereof, may be constructed from a polymericmaterial, a ceramic material and/or other various materials.Additionally, frame 46 may be manufactured via an injection molding oralternative polymer manufacturing methodologies. Alternatively, frame 46may be formed through a 3-D printing process, if desired. Further,different portions of frame 46 (as described above, for example), may bemade from a variety of materials and combined using alternativemethodologies. For example, attachment arms 64 may be made from apolymer material and combined with a central frame member constructedfrom a metal. Variations of combining different materials with differentportions of frame 46 are contemplated.

FIG. 4A further illustrates that attachment arms 64 may include avariety of shapes. For example, in some instances, attachment arms 64may include a bow and/or general curvilinear shape (such as that shownin the attachment arm 64 closest to head portion 58). In other examples,an attachment arm 64 may include additional features, such as thecircular portion 72 positioned along the attachment arm 64 (as shown inattachment arm 64 located farthest from head portion 58). In someinstances, the circular portion 72 may be designed to provide a “visualengagement marker” for which a user (e.g., clinician) may be able toengage a secondary medical device and manipulate the position of theframe 46 after initial deployment. In other words, a clinician may beable to engage a secondary medical device with circular portion 72 andthereafter manipulate the secondary medical device to alter the initialdeployment position of frame 46.

In some examples, frame 46 may include a variety of shapes and/orgeometric arrangements. For example, while the above discussion hasfocused on the shape of frame 46 shown in FIG. 4A, it is not intended tobe limiting. For example, frame 46 may include one or more stiffeningmembers 62 extending throughout frame 46. Further, stiffening members 62may be arranged within frame 46 (e.g., within body portion 56) such thatthey create one or more apertures 74. The number, shape, configurationand/or arrangement of stiffening members 62 and/or apertures 74 maydepend on the particular performance characteristics desired to beimparted to detachable frame 46. For example, additional stiffeningmembers 62 may be added to frame 46 to provide increased stiffness toframe 46. In other instances, stiffening members 62 may take onparticular geometries that increase stiffness or flexibility in aparticular direction while decreasing stiffness or flexibility in adifferent direction, for example.

Stiffening members 62 may be located (e.g., arranged) throughout frame46 in a variety of configurations to provide additional stiffness and/orstructural integrity to a particular frame shape. In other words, a widevariety of different shapes and/or arrangements of stiffening members 62may be included within frame 46 in order to impart customizedperformance characteristics of frame 46. For example, in some instances,it may be desirable to transfer rotational forces placed on head portion58 to attachment arms 64 positioned at the distal portion of frame 46.The addition of stiffening members 62 may allow transfer of thoserotational forces throughout frame 46 (e.g., to the distal portion offrame 46) while minimizing the amount of force lost and/or dissipatedthroughout the frame due to undesirable flexing of the frame members.

FIG. 4B shows another example of the frame 46. For purposes ofsimplicity, the reference numerals depicted in FIG. 4B may representanalogous elements described in FIG. 4A. As shown in FIG. 4B, frame 46may include a geometric shape that is similar to that described withrespect to frame 46 shown in FIG. 4A. However, as illustrated in FIG.4B, frame 46 may include stiffening members 62 extending and spaced in adifferent arrangement (as compared with the stiffening members 62 shownin FIG. 4A). Additionally, the frame 46 shown in FIG. 4B may includedifferent apertures 74 created by the alternative arrangement ofstiffening members 62.

FIGS. 4A and 4B further illustrate that frame 46 may include one or moreattachment apertures 70 located along a distal portion 68 of one or moreattachment arms 64. For example, FIGS. 4A/4B show attachment apertures70 positioned at a distal portion 68 of the attachment arms 64. As willbe discussed in greater detail below, attachment apertures 70 may beutilized to attach the frame 46 to an example implant 12.

While FIG. 4A shows three attachment apertures 70 positioned along adistal portion 68 of each of the attachment arms 64, the illustratednumber of attachment apertures 70 is not intended to be limiting. Inother embodiments, attachment apertures 70 may be located along anotherregion of attachment arms 64, such as a proximal portion of attachmentarms 64 proximate body portion 56. In other words, it is contemplatedthat one or more attachment arm apertures may be positioned along anyportion of frame 46. For example, FIG. 4B shows two attachment apertures70 positioned along a distal portion 68 of each of the attachment arms64. The number of attachment apertures positioned along frame 46 may be1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20 or more. In other instances,attachment arms 64 may be devoid of attachment apertures. In suchinstances, attachment arms 64 may include an alternative attachmentstructure for attaching to implant 12.

For simplicity purposes, when combined with an example implant 12, frame46 may be defined as having a first surface that faces away from theimplant 12 when implant 12 is attached to frame 46 (e.g., a firstsurface that faces away from a target site in the body) and a secondsurface that faces the example implant 12 (e.g., a second surface thatfaces a target site in the body). In some instances, attachmentapertures 70 may extend from the first surface to the second surface. Inother words, in some instances, attachment apertures 70 may be definedas holes and/or openings that extend through the thickness of frame 46from the first surface of the frame 46 that faces away from the implant12 to the second surface of the frame 46 that faces toward the implant12.

As stated above, attachment apertures 70 may be utilized to attachand/or couple frame 46 to an example implant 12. FIG. 5A shows anexample frame 46 attached to an example implant 12. Further, FIG. 5shows example frame 46 attached to example implant 12 at the distal orfree end of each of the four attachment arms 64, respectively.Attachment of free distal ends of attachment arms 64 to implant 12 maybe made by any desired attachment mechanism.

FIG. 5B shows a detailed view of a portion of the proximal portion 54 ofa frame 46 attached to an implant 12 in a configuration similar to thatdiscussed above with respect to FIGS. 2-4. Further, FIG. 5B showsexample attachment arm 64 including a distal portion 68. Threeattachment apertures 70 are positioned along the distal portion 68 ofthe attachment arm 64. Additionally, FIG. 5B shows an example attachmentmember (e.g. wire) 76 extending between and through one or more of theattachment apertures 70 located on the distal portion 68 of attachmentarms 64.

Attachment members 76 may be one of several structures and/or techniquescontemplated to attach example frame 46 to example implant 12. As shownin FIG. 5B, attachment member 76 may be positioned, looped, wound and/orthreaded through one or more attachment apertures 70 such that themember 76 is prevented from being pulled away from the distal portion 68of attachment arm 64. In other words, winding attachment member 76through one or more attachment apertures 70 may effectively affixattachment member 76 onto the attachment arm 64. In other words, it iscontemplated that attachment member 76 may be affixed to the distalportion 68 of attachment arms 64 (via attachment apertures 70, forexample) without having either end of the attachment member 76 directlyattached (e.g., welded, tied, etc.) to any structure (e.g., frame 46).In some instances, member 76 may be wrapped and/or looped throughattachment apertures 70 one or more times to provide a friction fitand/or resistive tension to unraveling or unwinding as a withdrawalforce is applied to attachment member 76.

While FIG. 5B shows a single attachment member 76 extending between twoattachment apertures 70, it is contemplated that attachment member 76may extend and/or wrap between two or more attachment apertures 70. Forexample, it is contemplated that attachment member 76 may be woven(e.g., over-and-under) through three apertures 70 in order to lockmember 76 to the distal end 68 of attachment arm 64.

The above discussion and the forgoing examples are not intended to limitthe disclosure to using an attachment member (e.g., wire, thread, cable,etc.) to attach frame 46 to implant 12. Rather, a variety ofmethodologies may be utilized to attach frame 46 to implant 12. Forexample, adhesives may be used alone or in combination with anotherattachment mechanism to attach frame 46 to implant 12. Additionally, avariety of injection molding techniques may be employed to attach frame46 to implant 12. Further, combinations of the disclosed techniques maybe used to attach frame 46 to implant 12. For example, an attachmentmember 76 may be used in conjunction with an adhesive to attach frame 46to implant 12 without having to wind attachment member 76 throughattachment apertures 70.

As stated above, it is contemplated in the examples discussed hereinthat frame 46 may be able to be “detached” from implant 12. For example,frame 46 may be configured to detach from implant 12 after implant 12has been affixed to a target site in the body, such as with staplesand/or sutures. Therefore, it can be appreciated that in some examplesdisclosed herein, frame member 46 may be temporarily attached to implant12. For example, frame member 46 may be coupled, affixed or attached toimplant 12 while positioned within delivery sheath 42, deployed out ofdelivery sheath 42 and maneuvered into position relative to a targetsite. Once positioned at the target site (e.g., along the tendon and/orhumeral head), implant 12 may be rigidly affixed to the target site,such as stapled and/or sutured to bone and/or tendon tissue at thetarget site. However, once implant 12 has been rigidly affixed to thetarget site, frame 46 may be pulled away (e.g., detached) from implant12 and removed from the body.

FIG. 5B shows an example attachment configuration which may allow frame46 to detach from implant 12. FIG. 5B shows attachment member 76 woundin a spiral pattern 80 along the surface of implant 12 facing a targetsite. In other words, attachment member 76 may form a spiral pattern 80that remains in a plane substantially parallel to the plane of thesurface of implant 12 which faces a target site. Further, it can beappreciated that attachment member 76 may extend from the side ofattachment arm 64 facing away from implant 12, through the combinedthickness of the attachment arm 64 and implant 12, eventually exitingimplant 12 on the surface of implant 12 facing a target site. Further,it can be appreciated that the spiral pattern 80 shown in FIG. 5B is oneof a variety of configurations for which attachment member 76 may bewound in order to prevent frame 46 from prematurely releasing fromimplant 12.

Attachment member 76 may have a first end secured to a free distal endof attachment arm 64 positioned on a first side of implant 12 and have asecond end positioned on a second, opposite side of implant 12. In someinstances, attachment member 76 may extend through implant 12 from thefirst side of implant 12 to the second side of implant 12. However, inother instances, attachment member 76 may extend around an edge ofimplant 12 from the first side of implant 12 to the second side ofimplant 12.

The attachment member 76 may be configured to be detached from implant12 upon application of a threshold level of force. For example, thespiral pattern 80 shown in FIG. 5B may provide frame 46 the ability todetach from implant 12 when a force greater than or equal to a threshold“pull-away force” is applied to frame 46. For example, after implant 12is affixed to a target site, a clinician may apply a force to frame 46(via a tether, for example) such that frame 46 is pulled away fromimplant 12. Provided the force is great enough (e.g., the thresholdforce is met), attachment members 76 (e.g., spiral portion 80 ofattachment member 76 shown in FIG. 5B) may be unwound and pulled backthrough the “body” (e.g., thickness) of implant 12, thereby releasingframe 46 from implant 12. In other words, provided a threshold pull-awayforce is applied to frame 46, the attachment member 76 forming thespiral 80 shown in FIG. 5B may unwind and pull back through implant 12.In some examples, the threshold “pull-away” force for the frame 46 torelease from implant 12 may be about 0.25 lb to 1.75 lb, or may be about0.75 lb to about 1.25 lb, or may be about 1.0 lb. Accordingly, thethreshold “pull-away” force to release each of the four attachmentmember 76 from implant 12 may be about 0.0625 lb to 0.4375 lb, or may beabout 0.1875 lb to about 0.3125 lb, or may be about 0.25 lb.

FIG. 5C shows another example method to attach frame 46 to an exampleimplant 12. As shown in FIG. 5C, attachment member 76 may include aspiral 81 positioned on the surface of the implant 12 which faces awayfrom a target site (similar to spiral 80 shown in FIG. 5B).Additionally, FIG. 5C shows that attachment member 76 may include asecond spiral 82 positioned on the surface of attachment arm 68 thatfaces away from implant 12. In other words, FIG. 5C shows two spirals81/82 formed at opposite ends of attachment member 76 and positioned onboth the attachment arm 64 facing away from implant 12 (e.g., spiral 82of FIG. 5C) and on the side of the implant 12 lying along a treatmentsite (e.g., spiral 81 of FIG. 5C). The configuration of spirals 81/82may provide a frame 46 with a “releasable” connection to implant 12similar to that discussed with respect to FIG. 5B.

FIG. 6 shows example frame 46 coupled to example implant 12 viaattachment members 76 as described above. Further, FIG. 6 shows frame 46in combination with implant 12 coupled to example implant deliverysystem 40. Similar to that discussed with respect to FIG. 2, implantdelivery system 40 includes implant delivery shaft 44 extending throughan example lumen 84 of an example delivery sheath 42.

Further, FIG. 6 shows the delivery shaft 44 coupled to frame 46 via aconnection assembly 88. Connection assembly 88 may include a firstconnection member 90 attached to the head portion 58 of frame 46 and asecond connection member 92 attached to the distal end 50 of deliveryshaft 44. While FIG. 6 does not directly show first connection member 90attached directly to second connection member 92, it can be appreciatedthat the first and second connection members 90/92 of connectionassembly 88 may form a mating connection. For example, in someinstances, first connection member 90 may form a male connection memberwhile second connection member 92 may form a mating female connectionmember. In other words, in some examples second connection member 92 mayinclude a cavity which is configured to extend over and allow firstconnection member 90 to be inserted therein. In other instances, thefirst connection member 90 may be a female connection member, whilesecond connection member 92 may be a mating male connection member.

Additionally, as shown in FIG. 6, it is contemplated that secondconnection member 92 may disengage or decouple from first connectionmember 90. For example, in some instances connection assembly 88(including first and second connection members 90/92) may be defined asa “quick release” connection assembly, or otherwise decouplingconnection assembly. It is further contemplated that a variety of designconfigurations may be employed to engage/disengage (i.e.,couple/decouple) the first and second connection members 90/92 from oneanother. For example, first and second connection members 90/92 may becoupled via a threaded connection, friction fit, spring loadedconnection, bayonet connection, movable collar or other actuationmechanism, or the like. Further, connection member 90/92 may beengaged/disengaged by an operator of the device.

In some instances, delivery shaft 44 may be attached (via connectionassembly 88, for example) to the head portion 58 of frame member 46. Asshown in FIG. 6, the first connection member 90 of connection assembly88 may attach to head portion 58 via an aperture 60 (shown in FIG. 3).In some instances, first connection member 90 may be attached to thehead portion 58 of frame member 46 via a variety of mechanical fasteningmeans (e.g., injection molding, encapsulation, bonding, etc.).

Additionally, in some instances, delivery system 40 may include a tether96 coupled to frame 46. For example, FIG. 6, as well as FIG. 16, showstether 96 attached to first connection member 90. However, it iscontemplated that in some examples tether 96 may be coupled directly orindirectly to frame 46 and/or any other suitable structure. Further,tether 96 may be a rigid structure (e.g., rod) or it may be a non-rigidstructure (e.g., a wire, cable, etc.). Additionally, it can beappreciated that tether 96 may be long enough to extend from frame 46positioned at the target site to a location exterior of the patientthrough insertion site (i.e., incision), such as through a lumen 86 ofdelivery shaft 44 and out of a proximal portion of the implant deliverysystem 40 (e.g., proximal portion of delivery shaft 44). However, it isalso contemplated that in some examples tether 96 may extend from frame46 outside of delivery shaft 44 and out of a proximal portion of theimplant delivery system 40. As will be discussed in greater detailbelow, the tether 96 may be utilized to withdraw the frame 46 out of thebody after the implant 12 has been attached.

As discussed above, in some instances, a physician may insert implantdelivery system 40 (including a delivery sheath 42, delivery shaft 44,frame 46 and implant 12) through an incision and position the distal endof the implant delivery system 40 adjacent a target implant site (e.g.,torn tendon). Once adjacent the target site, the physician maymanipulate the implant delivery shaft 44 to advance the implant (whileattached to the detachable frame 46) out of the delivery sheath 42adjacent the target implant site. For example, the physician may retractdelivery sheath 42 proximally relative to delivery shaft 44 and frame 46and/or may advance delivery shaft 44 and frame 46 distally relative todelivery sheath 42.

FIG. 6 shows frame 46 and implant 12 deployed from the distal portion 48of delivery sheath 42. In some instances, frame 46 and implant 12 mayhave a substantially concave shape with respect to delivery sheath 42.It can be appreciated that the concave shape of frame member 46 andimplant 12 may facilitate positioning the implant 12 along the generallyrounded shape of the human shoulder.

However, when positioned in the delivery sheath 42 (e.g., prior todeployment) the frame 46 and implant 12 may be wrapped around thedelivery shaft 44 in a convex configuration. Therefore, frame 46 andimplant 12 may shift from a first convex configuration (while wrappedtightly around delivery shaft 44 within lumen 84 of delivery sheath 42)to a second concave configuration when advanced (e.g., deployed) out ofsheath 42.

In other words, frame 46 and implant 12 may be attached to the deliveryshaft 44 via the connection assembly 88 when positioned within the lumen84 of the delivery sheath 42. In one example, when positioned within thedelivery sheath 42, the frame 46 and implant 12 may wrap, or extendaround, the delivery shaft 44. The position of the frame 46 and implant12 may be in a convex configuration with respect to the distal end 50 ofthe delivery shaft 44. As the frame 46 and implant 12 are deployed outof the distal end 50 of the delivery shaft 44, the frame 46 and implant12 may “shift” from a convex configuration to a concave configuration(as viewed with respect to the distal end 50 of delivery shaft 44).

FIG. 7 illustrates another example detachable frame member 146 attachedto an implant 112. It is contemplated that any of the frame membersand/or implants disclosed herein may be utilized in conjunction with anyof the delivery systems and/or delivery system features disclosedherein. Further, frame member 146 and/or implant 112 may be similar inform and functionality to other example frame members described herein.For example, detachable frame member 146 and implant 112 may have aproximal portion 152 which, for purposes of discussion herein, may beadjacent delivery shaft 44 (described above) and be configured to bepositioned adjacent humerus 16 (shown in FIG. 1). Further, detachableframe member 146 and implant 112 may have a distal portion 154 which,for purposes of discussion herein, may extend away from deliver shaft 44(described above) and be configured to be positioned adjacent tendon 24(shown in FIG. 1).

FIG. 8 shows example detachable frame member 146. As illustrated in FIG.8, frame member 146 may include a central body portion 156. In someexamples, body portion 156 may be understood to define a circular,ovular, square, rectangular or similar shaped framework from which othermembers may extend. For example, body portion 156 of frame 146 may bearsome resemblance to an elongated rectangle having a proximal portion 152and a distal portion 154. Body portion 156 may include one or moreapertures 174. Further, frame 146 may include a head portion 158positioned within and/or extending away from the body portion 156. Headportion 158 may include an aperture 160.

As shown in FIG. 8, detachable frame 146 may include one or moreattachment arms 164 extending away from body portion 156. Eachrespective attachment arm 164 may include a proximal portion 166 and adistal portion 168. The proximal portion 166 of each of the attachmentarms 164 may be rigidly attached to body portion 156, while the distalportion 168 may be a free end of the attachment arm 164 spaced away frombody portion 156. In some examples (such as that shown in FIG. 8),attachment arms 164 and head portion 158 may form a monolithic structurewith body portion 156. In other words, in some examples body portion156, head portion 158 and attachment arms 164 may be formed (e.g.,machined, cut, shaped, stamped, laser-cut, etc.) as a unitary structurefrom a single piece of material. However, the above discussion is notintended to be limiting. Rather, it is contemplated that detachableframe 146 may be constructed using alternative materials and/ormanufacturing methodologies. For example, frame 146, or portionsthereof, may be constructed from a polymeric material, a ceramicmaterial and/or other various materials. Additionally, frame 146 may bemanufactured via an injection molding or alternative polymermanufacturing methodologies. Alternatively, frame 146 may be formedthrough a 3-D printing process, if desired. Further, different portionsof frame 146 (as described above, for example), may be made from avariety of materials and combined using alternative methodologies. Forexample, attachment arms 164 may be made from a polymer material andcombined with a central frame member constructed from a metal.Variations of combining different materials with different portions offrame 146 are contemplated.

FIG. 8 further illustrates that attachment arms 164 may include avariety of shapes. For example, in some instances, attachment arms 164may include a bow and/or general curvilinear shape (such as that shownin the attachment arm 164 closest to head portion 158). In otherexamples, an attachment arm 164 may include additional features, such asthe circular portion 172 positioned adjacent one or more attachment arms164 (as shown adjacent two attachment arms 164 located farthest fromhead portion 158). Similar to that discussed above with respect tocircular portion 72 shown in FIG. 4A, the circular portion 172 may bedesigned to provide a “visual engagement marker” for which a user (e.g.,clinician) may be able to engage a secondary medical device andmanipulate the position of the frame 146 after initial deployment. Inother words, a clinician may be able to engage a secondary medicaldevice with circular portion 172 and thereafter manipulate the secondarymedical device to alter the initial deployment position of frame 146.

In some examples, frame 146 may include a variety of shapes and/orgeometric arrangements. For example, while the above discussion hasfocused on the shape of frame 146 shown in FIG. 8, it is not intended tobe limiting. For example, frame 146 may include one or more stiffeningmembers 162 extending throughout frame 146, such as throughout bodyportion 156. Further, stiffening member 162 may be arranged within frame146 (e.g., within body portion 156) such that it creates the one or moreapertures 174. The number, shape, configuration and/or arrangement ofstiffening members 162 and/or apertures 174 may depend on the particularperformance characteristics desired to be imparted to detachable frame146. For example, additional stiffening members 162 may be added toframe 146 to provide increased stiffness to frame 146. In otherinstances, stiffening members 162 may take on particular geometries thatincrease stiffness or flexibility in a particular direction and/orregion while decreasing stiffness or flexibility in a differentdirection and/or region, for example.

Stiffening members 162 may be located (e.g., arranged) throughout frame146 in a variety of configurations to provide additional stiffnessand/or structural integrity to a particular frame shape. In other words,a wide variety of different shapes and/or arrangements of stiffeningmembers 162 may be included within frame 146 to impart customizedperformance characteristics on frame 146. For example, in some instancesit may be desirable to transfer rotational forces placed on head portion158 to attachment arms 164 positioned at the distal portion 154 of frame146. The addition of stiffening members 162 may transfer thoserotational forces throughout frame 146 (e.g., to the distal portion 154of frame 146) while minimizing the amount of force lost and/ordissipated throughout the frame 146 due to undesirable flexing of theframe members.

FIG. 8 further illustrates that frame 146 may include an extensionmember 180 extending away from head portion 158 (when viewed in theplanar configuration shown in FIG. 8). Extension member 180 may includea connection aperture 182 formed in a proximal region 184 of extensionmember 180. Additionally, extension member 180 may include one or moreextension arms 186 extending to a proximal portion of body portion 156.Extension arms 186 may be part of (e.g., a monolithic structure with)body portion 156. FIG. 8 illustrates that extension arms 186 may includea curve. However, it is contemplated that the shape of extension portion180 (including extension arms 186 and/or aperture 186) may include avariety of shapes and/or configurations.

FIG. 8 further illustrates that frame 146 may include one or moreattachment channels 170 located along a distal portion 168 of one ormore attachment arms 164. For example, FIG. 8 shows attachment channels170 positioned at a distal portion 168 of the attachment arms 164. Aswill be discussed in greater detail below, attachment channels 170 maybe utilized to attach the frame 146 to an example implant. While FIG. 8shows a single attachment channel 170 positioned along a distal portion168 of each of the attachment arms 164, the illustrated number ofattachment channels 170 is not intended to be limiting. In other words,it is contemplated that one or more attachment channels 170 may bepositioned along any portion of frame 146. The number of attachmentchannels 170 positioned along frame 146 may be 1, 2, 3, 4, 5, 6, 7, 8,9, 10, 15, 20 or more. In other instances, attachment arms 164 may bedevoid of attachment channels 170. In such instances, attachment arms164 may include an alternative attachment structure for attaching to animplant.

When combined with an example implant, frame 146 may be defined ashaving a first surface that faces away from the implant when the implantis attached to frame 146 (e.g., a first surface that faces away from atarget site in the body) and a second surface that faces the exampleimplant (e.g., a second surface that faces a target site in the body).In some instances, attachment channels 170 may extend from the firstsurface to the second surface. In other words, in some instances,attachment channels 170 may be defined as openings that extend throughthe thickness of frame 146 from the first surface of the frame 146 thatfaces away from the implant to the second surface of the frame 146 thatfaces toward the implant.

As stated above, attachment channels 170 may be utilized to attachand/or couple frame 146 to an example implant. FIG. 9A shows an exampleframe 146 attached to an example implant 112. Further, FIG. 9A showsexample frame 146 attached to example implant 112 at the distal or freeend of each of the four attachment arms 164, respectively. Attachment offree distal ends of attachment arms 164 to implant 112 may be made byany desired attachment mechanism.

As will be described in greater detail below, FIG. 9A furtherillustrates locking covers 198 positioned along the distal portion 168of attachment arms 164. Locking cover 190 may be used in conjunctionwith attachment channels 170 to secure frame 146 to implant 112. Lockingcovers 198 may be constructed of a variety of materials. For example,locking covers 198 may include a metal, a polymer or combinationsthereof, for example.

FIG. 9B shows a detailed view of a portion of frame 146 attached to animplant 112 in a configuration similar to that discussed above withrespect to FIGS. 7 and 8. Specifically, FIG. 9B shows example attachmentarm 164 including a distal portion 168. Attachment channels 170 arepositioned along the distal portion 168 of the attachment arm 164.Additionally, FIG. 9B shows an example attachment member (e.g. wire) 176extending between and/or through one or more of the attachment channels170 located on the distal portion 168 of attachment arms 164.

Attachment member 176 may include a variety of structures and/ortechniques designed to attach example frame 146 to example implant 112.As shown in FIG. 9B, attachment member 176 may be inserted, looped,wound and/or threaded through one or more attachment channels 170 suchthat the attachment member 176 is prevented from being pulled away fromthe distal portion 168 of attachment arm 164. In other words, sliding,inserting and/or winding attachment member 176 through one or moreattachment channels 170 may effectively affix attachment member 176 toattachment arm 164. In other words, it is contemplated that attachmentmember 176 may be affixed to the distal portion 168 of attachment arms164 (via attachment channels 170, for example) without having either endof the attachment member 176 permanently attached (e.g., welded, etc.)to any structure (e.g., frame 146). In some instances, attachment member176 may be wrapped and/or looped through attachment channel 170 one ormore times to provide a friction fit, interference fit, and/or resistivetension to unraveling or unwinding as a withdrawal force is applied toattachment member 176.

FIG. 9B further illustrates that attachment channel 170 may include anopening that extends through the thickness of attachment arm 164 (e.g.,from a top surface to the bottom surface of attachment arm 164) and alsothat attachment channel 170 may extend through the sidewall 171 ofattachment arm 164 such that attachment member 176 may be laterallyinserted into and/or removed from attachment channel 170. Additionally,attachment channel 170 may include one or more widths along the lengthof attachment channel 170. For example, FIG. 9B shows attachment channel170 including a first width “X” which extends through sidewall 171 ofattachment arm 164. Attachment channel 170 further includes a secondwidth “Y.” In some instances, width “X” may be narrower than width “Y.”Further, it can be appreciated that width “X” may be sized such that itis slightly smaller than the width (e.g., diameter) of attachment member176. Additionally, the general shape of attachment channel 170 may bedesigned such that it may flex to an extent sufficient to permitattachment member to extend (e.g., be inserted) through the narrowerportion of channel 170 defined by the width “X” and further advancedinto the wider portion of channel 170 defined by width “Y.”

FIG. 9B further illustrates example detents 173. Detents may extendinwardly from the surface of sidewall 171. In some instances, detents173 may be designed to mate with a protrusion or tab extending from aninner surface of locking member 198. Alternatively, detents may beprotrusions or protuberances extending from the surface of attachmentarm 164 configured to engage and/or mate with a feature of locking cover198.

Similar to that described above with respect to FIG. 5B, FIG. 9B showsan example attachment configuration which may allow frame 146 to detachfrom implant 112. For example, FIG. 9B shows a portion of attachmentmember 176 wound in a spiral pattern 180 along the surface of implant112 facing a target site. In other words, attachment member 176 may forma spiral pattern 180 that remains in a plane substantially parallel tothe plane of the surface of implant 112 which faces a target site.Further, it can be appreciated that attachment member 176 may extendfrom the side of attachment arm 164 facing away from implant 112,through the combined thickness of the attachment arm 164 (e.g., viaattachment channel 170) and implant 112, eventually exiting implant 112on the surface of implant 112 facing a target site. The attachmentmember 176 may include a retention portion, such as a spiral pattern 180positioned on the opposite side of implant 112 from attachment arm 164for coupling implant 112 to attachment arm 164. Further, it can beappreciated that the spiral pattern 180 shown in FIG. 9B is one of avariety of configurations for which attachment member 176 may be woundin order to prevent frame 146 from prematurely releasing from implant112. Further, as described above, when a sufficient threshold pull-awayforce is applied to frame 146, the portion of attachment member 176forming the spiral 180 shown in FIG. 9B may unwind and/or straighten andpull back through implant 112. Instead of spiral 180, it is contemplatedthat attachment member 176 may have another shaped configurationpositioned on the surface of implant 112 facing a target site, which maybe straightened or release upon a sufficient removal force to pull backthrough implant 112.

FIG. 9B further shows locking member 198 positioned along the distalportion 168 of attachment arm 164. In at least some examples disclosedherein, locking member 198 may be able to translate (e.g., slide) alongattachment arm 164. For example, FIG. 9B shows the distal portion 168 ofattachment arm 164 extending through at least a portion of lockingmember 198. In such instances, locking member 198 may be a sleeve inwhich attachment arm 164 extends through lumen of sleeve. In at leastsome examples disclosed herein, locking member 198 is designed such thatthere is sufficient clearance between the inner surface (e.g., the innerdiameter) of locking member 198 and the outer surface (e.g., the outerdiameter) of attachment arm 164 such that locking member 198 can slidealong attachment arm 164.

It can further be appreciated that locking member 198 may slide alongattachment arm 164 to a position in which locking member 198 coversattachment member 176 and/or attachment channel 170. For example, FIG.9C shows locking member 198 positioned at the distal end 168 of theattachment arm 164. Further, FIG. 9C shows locking member 198 positionedover the top (e.g., covering) of attachment member 176 and attachmentchannel 170. It can be appreciated that when positioned over the top ofthe attachment member 176 and/or attachment channel 170, locking member198 may pinch, hold, secure, and/or lock attachment member 176 toattachment arm 164, such as by securing or locking attachment member 176in attachment channel 170. In some examples, locking member 198 mayresemble a “compression-like” fitting wherein locking member 198 isdrawn over the top of attachment member 176, thereby compressingattachment member 176 onto attachment arm 164 such that attachmentmember 176 is prevented from separating from attachment arm 164.

Additionally, when locking member 198 is positioned over the top ofattachment member 176 and/or attachment channel 170, locking member 198may lock in place via detents 173. In other words, when locking member198 is positioned in its securement position, in which the attachmentmember 176 is secured to attachment arm 164, a feature of locking member198 engages detents 173 to inhibit or prevent locking member 198 frommoving back to the unsecured position shown in FIG. 9B. For example, itcan be appreciated that the locking member 198 may include one or moreinwardly projecting tabs (not shown) designed to be inserted (e.g., matewith) detents 173. The combination of tabs and detents 173 are,therefore, designed to prevent locking member 198 from moving alongattachment arm 164 after having been positioned over top the attachmentmember 176 and/or attachment channel 170.

During assembly of implant 112 to frame 146, attachment member 176 maybe passed through implant 112 with distal enlarged portion (e.g., spiral180) positioned on a second surface of implant 112 facing away fromframe 146. Portion of attachment member 176 extending from a firstsurface of implant 112 facing frame 146 may then be passed throughattachment channel 170, such as passed laterally into attachment channel170 and then bent, wound or otherwise manipulated around attachment arm164. Locking member 198 may then be moved from a first, unsecuredposition, shown in FIG. 9B to a second, secured position, shown in FIG.9C to secure attachment member 176 to attachment arm 164.

The above discussion describes example configurations of the distal endportions of the attachment arms and provides example configurations ofhow the attachment arms may be connected to an example implant. However,these configurations are not intended to be limiting. Rather, a varietyof attachment arm configurations are contemplated. For example, FIG. 9Dshows a detailed view of a portion of another example frame 246 attachedto implant 112 in a configuration similar to that discussed above withrespect to FIGS. 9A-9C.

Specifically, FIG. 9D shows example attachment arm 264 including adistal portion 268. An attachment channel 270 is positioned along thedistal portion 268 of the attachment arm 264. Additionally, FIG. 9Dshows an example attachment member (e.g. wire) 276 extending through theattachment channel 270 located on the distal portion 268 of attachmentarm 264. FIG. 9D further illustrates that the distal portion 268 of theattachment arm 264 may include one or more openings 273 that extendthrough the thickness of attachment arm 264 (e.g., from a top surface tothe bottom surface of attachment arm 264) and also that attachmentchannel 270 may extend through the sidewall 271 of attachment arm 264such that attachment member 276 may be laterally inserted into and/orremoved from attachment channel 270. As illustrated in FIG. 9D,attachment member 276 may be looped through one or more openings 273 andimplant 112 (the dashed line in FIG. 9D depicts the attachment member276 being looped through implant 112) in addition to being securedwithin attachment channel 270.

Attachment member 276 may include a variety of structures and/ortechniques designed to attach example frame 246 to example implant 112.As shown in FIG. 9D, attachment member 276 may be inserted, looped,wound and/or threaded through one or more attachment channels 270 and/oropenings 273 such that the attachment member 276 is prevented from beingpulled away from the distal portion 268 of attachment arm 264. In otherwords, sliding, inserting and/or winding attachment member 276 throughone or more attachment channels 270 and/or openings 273 may effectivelyaffix attachment member 276 to attachment arm 264. In other words, it iscontemplated that attachment member 276 may be affixed to the distalportion 268 of attachment arms 264 (via attachment channels 270 and/oropenings 273, for example) without having either end of the attachmentmember 276 permanently attached (e.g., welded, etc.) to any structure(e.g., frame 246). In some instances, attachment member 276 may bewrapped and/or looped through attachment channel 270 and/or openings 273one or more times to provide a friction fit, interference fit, and/orresistive tension to unraveling or unwinding as a withdrawal force isapplied to attachment member 276.

Further, FIG. 9E illustrates that in some examples, a locking member 298may be molded directly onto and/or otherwise positioned on the distalportion 268 of attachment arm 264. For example, FIG. 9E shows an examplelocking member 298 positioned along the distal portion 268 of theattachment arm 264 whereby the locking member 298 covers at least aportion of the attachment member 276 and/or attachment channel 270.Further, FIG. 9E shows locking member 298 encircling (e.g., covering)attachment member 276 and attachment channel 270. It can be appreciatedthat when molded over attachment member 276 and/or attachment channel270, the locking member 298 may pinch, hold, secure, and/or lockattachment member 276 to attachment arm 264, such as by securing orlocking attachment member 276 in attachment channel 270 and/or openings273. In some examples, locking member 298 may compress attachment member276 onto attachment arm 264 such that attachment member 276 is preventedfrom separating from attachment arm 264. It is contemplated that any ofthe examples described herein may utilize a sliding locking member 198(as shown and described in FIGS. 9A-9C) and/or an over-molded lockingmember 298 (as shown and described in FIG. 9E).

FIG. 10 illustrates a perspective view of frame 146 representing theconfiguration frame 146 would be in when inserted into the body. Forexample, FIG. 10 shows frame 146 including extension member 180 coupledto both connection member 90 (similar in form and function to connectionmember 90 discussed above) and head portion 158. As discussed above,FIG. 10 illustrates that a tether 96 (similar in form and function totether 96 discussed above) may be coupled to connection member 90 andextend proximally therefrom. Further, as illustrated in FIG. 10,extension member 180 may curve upward and back on itself (e.g., upwardand back toward the distal end 154 of frame 146). Further, head portion158 may extend upward and away from the body portion 156 of frame 146.It can be appreciated that connection member 90 may couple extensionmember 180 to head portion 158 via the apertures 182 and 160. In otherwords, connection member 90 may be inserted through both apertures 182and 160, thereby securing extension member 180 to head portion 158.Additionally, FIG. 10 shows a tack member 94 extending through a portionof frame 146. Tack member 94 will be described in greater detail below.

Additionally, FIG. 10 illustrates that frame 146 may form a concaveconfiguration when being inserted into the body. It can be appreciatedthat the concave shape of frame 146 may follow the contour of anatomy(e.g., shoulder) in which the example implant is to be secured.

FIG. 11 illustrates a side view of frame 146 described in FIG. 10. FIG.11 illustrates the concave shape of frame 146. Additionally, FIG. 11shows extension member 180 curving upward and back toward distal portion154 of frame 146 as described above. Further, FIG. 11 shows head portion158 extending upward and away from body portion 156 of frame 146.Extension member 180 and the head portion 158 are coupled to one anothervia connection member 90 extending through connection apertures 182,160. Thus, connection apertures 182, 160 may be coaxial, with connectionmember 90 extending therethrough. Additionally, FIG. 11 shows tackmember 94 extending through a portion of frame 146, such that the distaltip of tack member 94 penetrates through implant 112 to be positioned adistance below the lower surface (the surface of implant 112 oppositethe frame 146) of implant 112. FIG. 11 further illustrates the tethermember 96 described above with respect to FIG. 10. In some examples, thetether member 96 may be coupled to the tack member 94. While the abovediscussion describes the tether member 96 indirectly coupled to framemember 146 via the connection member 90, it is contemplated that inother instances the tether member 96 may be directly coupled to frame146 (or other similar frame members described herein).

In some instances, the configuration of frame 146 shown in FIGS. 7-11may provide both precise control and maneuverability to a clinician orother operator of the medical device. For example, the geometry of theextension member 180 in combination with head portion 158 and connectionmember 90 may provide precise maneuverability of the distal portion 154of frame 146. For example, in some instances, an operator may manipulateconnection member 90 with a delivery shaft 44 (described above). Thedelivery shaft may be able to impart a downward force (e.g., a forcedirected toward a patient's shoulder) onto frame 146 via the combinationof connection member 190, extension member 180 and head portion 158.Further, the concave geometry of frame 146 may allow the distal portionof frame 146 to extend along the surface of the shoulder for which theimplant 112 is to be positioned. In other words, the geometry of frame146 shown in FIG. 10 and FIG. 11 may prevent the distal portion 154 offrame 146 (including attachment arms 164) from pulling up and away fromthe shoulder surface as a clinician manipulates frame 146 within thebody. Further, the geometry of frame 146 shown in FIGS. 10 and 11 mayallow the distal portion 154 of frame 146 to be advanced toward thesurface of the shoulder in which an implant 112 is to be positioned.

Additionally, the geometry of frame 146 shown in FIG. 11 may allow aclinician improved visibility of the frame 146 (e.g., the distal portion154 of frame 146) during implantation of the medical device. Forexample, in some instances a clinician may position a camera adjacentthe implantation site. The clinician may utilize the camera toaccurately maneuver and/or position an example implant into the patient.However, in some instances, the camera my obscure and/or impede thevisibility of all or a portion of the frame or implant (e.g., frame 146and/or implant 112). However, the geometry of frame 146 shown in FIG. 11may allow the connection member 90 (and delivery sheath 44 coupled toconnection member 90) to be inserted at an angle (depicted as “θ” inFIG. 11) which is directed away from the distal end 154 of frame 146. Itcan be appreciated that angle θ may be measured from a line 155 that isorthogonal to a line 151 tangent to a point 153 generally positioned atthe apex of a curve defined by body portion 156. Orienting connectionmember 90 such that it is directed away from the distal end 154 of frame146 may increase the amount of space for which a camera may be placedduring a procedure. In other words, a clinician may be able to maneuverthe camera such that it provides improved visibility of all or a portionof the medical device being implanted (e.g., implant 112 via frame 146).

As briefly described above with respect to FIGS. 10 and 11, any of theimplant delivery systems described herein may include a tack memberdesigned to “anchor” the delivery system in place prior to a clinicianaffixing implant 12 to the bone and/or tendon. For example, FIG. 12Aillustrates a tack member 94 extending distally from the firstconnection member 90. As shown in FIG. 12A, tack member 94 may extenddistally from first connection member 90 and be substantiallyperpendicular to implant 12 and/or frame 46. In some instances, tackmember 94 may extend generally parallel to the longitudinal axis ofdelivery sheath 42 and/or delivery shaft 44 with the frame 46 andimplant 12 extending generally perpendicular to the longitudinal axis ofdelivery sheath 42 and/or delivery shaft 44. However, this configurationis not intended to be limiting. Rather, it is contemplated that tackmember 94 may extend distally from the first connection member 90 and/orframe 46 at an oblique angle to the longitudinal axis of delivery sheath42, delivery shaft 44, and/or frame 46.

In some instances, tack member 94 may resemble a cylindrical pin or rodextending away from frame 46. The tack member 94 may be designed to berigid enough to be pounded and/or inserted into bone. For example, insome instances, a clinician may apply a force to a proximal portion ofthe implant delivery system 40 (e.g., delivery shaft 44) such that tackmember 94 may be “hammered” into a body structure (e.g., bone). In someinstances, tack member 94 may include a tapered distal tip, which may bea sharpened or blunt tapered distal tip in some instances.

In some instances, tack member 94 may be stationary (e.g., fixed inplace) relative to frame 46 and/or first connection member 90 ofconnection assembly 88. For example, tack member 94 may extend distallyfrom first connection member 90 and away from the surface of frame 46which faces a target site.

While the above discussion describes example tack member 94, thediscussion relative thereto is not intended to be limiting. Rather, avariety of tack member designs and configurations are contemplatedherein. Different tack members may be designed to impart specificinsertion forces while the tack is being driven into a body structure(e.g., bone). Additionally, these tack designs may also provide specificrelease forces upon removing the tack from a body structure (e.g.,bone).

For example, FIG. 12B illustrates another tack member 394. Tack member394 may include a proximal end region 340 and a distal end region 350.The distal end region 350 may include shaft member 352 and a tip member354. The tip member 354 may be positioned at the distal end of the shaftmember 352. Additionally, in some examples the tack member 394 mayinclude one or more radially enlarged portions positioned along theshaft member 352. Radially enlarged portions may be protuberances orlobes (e.g., continuous or discontinuous circumferential and/or helicalrims, etc.) extending radially outward beyond the outer surface of theshaft member 352, for example. For example, FIG. 12B shows a firstradially enlarged portion 356A and a second radially enlarged portion356B positioned along the shaft member 352. However, it is contemplatedthat the tack member 394 may include a single radially enlarged portionor more than two radially enlarged portions. For example, the tackmember 394 may include 1, 2, 3, 4, 5, 6, 7, 8 or more radially enlargedportions. In some examples, the first radially enlarged portion 356A maybe positioned adjacent tip member 354.

In some examples the proximal end region 340 of the tack member 394 mayinclude a vertical bore 355 extending inward from a proximal end surface357 of the tack member 394. The vertical bore 355 may extend along thelongitudinal axis 359 of the tack member 394. Additionally, FIG. 12Billustrates the tether member 96 (discussed with respect to FIG. 12A)extending within the vertical bore 355. As shown in FIG. 12B, thevertical bore 355 may include a profile which mirrors the shape of thetether member 96 extending within the vertical bore 355. It can furtherbe appreciated that the tether member 96 may be attached to the tackmember 394 via the vertical bore 355. In other words, the tether member96 may be rigidly fixed to the tack member 394 within the vertical bore355 via a variety of attachment techniques (e.g., welding, adhesive,crimping, swaging, etc.) The diameter of the tether member 96 isillustrated as being less than the diameter of the vertical bore 355,however, it is noted that upon securement of the tether member 96 withinvertical bore 355, the tether member 96 may substantially occupy thebore 355.

FIG. 12B illustrates that the first radially enlarged portion 356A andthe second radially enlarged portion 356B may be spaced longitudinallyaway from one another along the shaft member 352 with a portion of theshaft 352 positioned therebetween. For example, FIG. 12B shows thedistance at which each of the first radially enlarged portion 356A andthe second radially enlarged portion 356B are spaced away from thedistal end 360 of the tip member 354. For example, “X₁” depicts thedistance at which the first radially enlarged portion 356A is spacedaway from the distal end 360 of the tip member 354. In some examples, X₁may be between 0.030 inches and 0.090 inches, or may be between 0.045inches and 0.075 inches, or may be about 0.059 inches, for example.Additionally, “X₂” depicts the distance at which the second radiallyenlarged portion 356B is spaced away from the distal end 360 of the tipmember 354. In some examples, X₂ may be between 0.100 inches and 0.150inches, or may be between 0.115 inches and 0.130 inches, or may be about0.124 inches.

However, it is further contemplated that in some examples the firstradially enlarged portion 356A and the second radially enlarged portion356B may be adjacent one another. In other words, it is contemplatedthat the first radially enlarged portion 356A and the second radiallyenlarged portion 356B may be positioned directly adjacent one another.It is further contemplated that in some examples the tack member 394 mayinclude more than two radially enlarged portions, some of which may bepositioned away from other radially enlarged portions and/or some ofwhich may be positioned directly adjacent other radially enlargedportions.

Additionally, the detailed view of FIG. 12B illustrates that the firstradially enlarged portion 356A and/or the second radially enlargedportion 356B may include a curved portion 357 having an outer surfacewhich extends laterally away from the outer surface of the shaft member352 located adjacent to the curved portion 357. In other words, thecurved portion 357 of the radially enlarged portion 356 may have anouter diameter which is greater than the outer diameter of the shaftmember 352 directly adjacent the curved portion 357. For example, thedetailed view of FIG. 12B depicts the distance that curved portion 357extends radially outward from the surface of the shaft member 352 as“X₃.” In some examples, X₃ may be between 0.001 inches and 0.015 inches,or may be between 0.005 inches and 0.010 inches, or may be about 0.006inches. In some examples, the distance that a first radially enlargedportion and a second radially enlarged portion extends away from thesurface of the shaft member 352 may be different. For example, a moreproximal radially enlarged portion may extend radially outward from theshaft member 352 a greater distance or a lesser distance than a moredistal radially enlarged portion. In other examples (like thosedescribed above), the distance that a first radially enlarged portionand a second radially enlarged portion extends away from the surface ofthe shaft member 352 may be substantially equivalent.

It can be appreciated that the distance that curved portion 357 extendsradially away from the surface of the shaft member 352 may correspond tothe force required to retract the tack member 394 from a body structureinto which the tack 394 may be inserted. It can further be appreciatedthat the shape, geometry, materials, etc. of the tack member 394 may betailored to impart specific withdrawal forces from a body structure intowhich the tack member 394 may be inserted.

Additionally, in some instances, the shaft member 352 may include ataper. For example, the shaft member 352 may be tapered at an anglerelative to the longitudinal axis 359 of the shaft member 352. In someexamples, angle of taper may be about 1 degree to about 5 degrees, forexample.

FIG. 12C illustrates another example tack member 494. The tack member494 may be similar in form and function to other tack members describedherein. For example, tack member 494 may include a proximal end region440 and a distal end region 450. The distal end region 450 may includeshaft member 452 and a tip member 454. The tip member 454 may bepositioned at the distal end of the shaft member 452. The tack member494 may further include the vertical bore 455. FIG. 12C illustrates thetether member 96 extending within the vertical bore 455. The tethermember 96 may be attached to the tack member 494 via the vertical bore455 as described above.

Additionally, FIG. 12C illustrates that shaft member 452 may include oneor more radially enlarged portions 462 positioned helically along theshaft member 452. Similarly to the radially enlarged portions 356A/356Bdescribed above with respect to FIG. 12B, the helical radially enlargedportion 462 may include a curved portion having an outer surface whichextends radially outward beyond the outer surface of the shaft member452. As illustrated in FIG. 12C, the helical radially enlarged portion462 may extend longitudinally along the shaft member 452 in a helicalfashion. Additionally, while FIG. 12C shows a single helical radiallyenlarged portion extending along the surface of the shaft member 452, itis contemplated that the tack member 494 may include more than onehelical radially enlarged portion 462. For example, tack member 494 mayinclude two helical radially enlarged portions helically arranged alongthe shaft member 452. In some examples, first and second helicalradially enlarged portions may extend around shaft member 452 in thesame helical direction (e.g., a clockwise direction or acounterclockwise direction) along shaft member 452. In some examples,first and second helical radially enlarged portions may extend aroundshaft member 452 in opposite directions (e.g., a first helical radiallyenlarged portion extending in a clockwise direction and a second helicalradially enlarged portion may extend in a counterclockwise direction)along shaft member 452.

FIG. 12D illustrates another example tack member 594. The tack member594 may be similar in form and function to other tack members describedherein. For example, tack member 594 may include a proximal end region540 and a distal end region 550. The distal end region 550 may includeshaft member 552 and a tip member 554. The tip member 554 may bepositioned at the distal end of the shaft member 552. The tack member594 may further include the vertical bore 555. FIG. 12D illustrates thetether member 96 extending within the vertical bore 555. The tethermember 96 may be attached to the tack member 594 via the vertical bore555 as described above.

Additionally, FIG. 12D illustrates that tack member 594 may be formed asa composite structure including multiple components formed of dissimilarmaterials. For example, tack member 594 may include shaft member 552along with one or more fixation members 564 disposed along the shaftmember 552 (depicted by the dashed line in FIG. 12D). As shown in FIG.12D, the fixation members 564 may be constructed from materialsdifferent from the material used to construct the shaft member 552. Forexample, the fixation members 564 may be formed from a material which issofter and/or more flexible than the material used to construct theshaft member 552, thus permitting the fixation members 564 to beradially compressible toward the longitudinal axis of the tack member594. The fixation members 564 may include a polymeric material,composite material, or any other material with desirablecompression/expansion characteristics, while the shaft member 552 may beformed of a metallic material, for example.

As illustrated in FIG. 12D, the one or more fixation members 564 maysurround or otherwise extend radially outward from the surface of theshaft member 552 with the shaft member 552 extending through the one ormore fixation members 564. In some instances, the one or more fixationmembers 564 may be positioned in one or more grooves or recesses formedin an outer surface of the shaft member 552. It can be appreciated thatthe fixation members 564 may be designed to provide a specificwithdrawal force from a body structure into which the tack member may beinserted. For example, the fixation members 564 may be designed from amaterial having a selected modulus which allows the material to becompressed while inserted into a body structure. However, this materialmay also permit the fixation members 564 to impart a specificradially-outward force against the body structure while inserted intothe body structure. This radially-outward force may correspond to theforce required to remove the tack member 594 from the body structure.Thus, radial compression of the fixation members 564 may be necessaryfor insertion of the tack member 594 into a body structure (e.g., bone)and removal of the tack member 594 from the body structure (e.g., bone).The materials, number, geometry, spacing, etc. utilized for the fixationmembers 564 may be tailored to provide a particular “release” forcecorresponding to a maximum threshold force that a clinician may want toimpart on tack member 564 to remove it from the body structure.

FIG. 12E illustrates another tack member 694. Tack member 694 mayinclude a proximal end region 640 and a distal end region 650. Thedistal end region 650 may include shaft member 652 and a tip member 654.The tip member 654 may be positioned at the distal end of the shaftmember 652. Additionally, in some examples the tack member 694 mayinclude one or more radially extending portions positioned along theshaft member 652. Radially extended portions may be protuberances (e.g.,continuous or discontinuous circumferential and/or helical flats, etc.)extending radially outward beyond the outer surface of the shaft member652, for example. For instance, FIG. 12E shows a radially extendingportion 653A positioned along the shaft member 652 and extendingradially outward from the outer surface of shaft member 652.Additionally, FIG. 12E shows a second radially extending portion 653Bpositioned adjacent to and/or extending from tip member 654. However, itis contemplated that the tack member 694 may include a single radiallyextending portion or more than two radially extending portions. Forexample, the tack member 694 may include 1, 2, 3, 4, 5, 6, 7, 8 or moreradially extending portions. In some examples, the first radiallyenlarged portion 652A may be positioned adjacent tip member 654.

In some examples, the proximal end region 640 of the tack member 694 mayinclude a vertical bore 655 extending inward from a proximal end surface657 of the tack member 694. The vertical bore 655 may extend along thelongitudinal axis 659 of the tack member 694. Additionally, FIG. 12Eillustrates the tether member 96 (discussed with respect to FIG. 12A)extending within the vertical bore 655. As shown in FIG. 12E, thevertical bore 655 may include a profile which mirrors the shape of thetether member 96 extending within the vertical bore 655. It can furtherbe appreciated that the tether member 96 may be attached to the tackmember 694 via the vertical bore 655. In other words, the tether member96 may be rigidly fixed to the tack member 694 within the vertical bore655 via a variety of attachment techniques (e.g., welding, adhesive,crimping, swaging, etc.) The diameter of the tether member 96 isillustrated as being less than the diameter of the vertical bore 655,however, it is noted that upon securement of the tether member 96 withinvertical bore 655, the tether member 96 may substantially occupy thebore 655.

FIG. 12E illustrates that the first radially extending portion 653A andthe second radially extending portion 653B may be spaced longitudinallyaway from one another along the shaft member 652 with a portion of theshaft 652 positioned therebetween. For example, FIG. 12E shows thedistance at which each of the first radially extending portion 653A andthe second radially enlarged portion 653B are spaced away from thedistal end 660 of the tip member 654. For example, “X₅” depicts thedistance at which the first radially extending portion 653A is spacedaway from the distal end 660 of the tip member 654. In some examples, X₅may be between 0.090 inches and 0.175 inches, or may be between 0.115inches and 0.150 inches, or may be about 0.127 inches, for example.Additionally, “X₄” depicts the distance at which the second radiallyextending portion 653B is spaced away from the distal end 660 of the tipmember 654. In some examples, X₄ may be between 0.025 inches and 0.100inches, or may be between 0.050 inches and 0.075 inches, or may be about0.062 inches.

However, it is further contemplated that in some examples the firstradially extending portion 653A and the second radially enlarged portion653B may be adjacent one another. In other words, it is contemplatedthat the first radially extending portion 653A and the second radiallyenlarged portion 653B may be positioned directly adjacent one another.It is further contemplated that in some examples the tack member 694 mayinclude more than two radially extending portions, some of which may bepositioned away from other radially extending portions and/or some ofwhich may be positioned directly adjacent other radially extendingportions.

Additionally, the detailed view of FIG. 12E illustrates that the firstradially enlarged portion 653A and/or the second radially enlargedportion 653B may include a rim or lip portion 651 having a radiallyextending tip 655 which extends laterally away from the outer surface ofthe shaft member 652. The radially extending portion 653A (including rimor lip portion 651) may have an outer diameter which is greater than theouter diameter of the shaft member 652. For example, FIG. 12E shows thediameter of the rim or lip portion 651 extending radially outward fromthe surface of the shaft member 652 as “D₂” and the diameter of theshaft member 652 as “D₁.” In some examples, D₂ may be between 0.035inches and 0.100 inches, or may be between 0.050 inches and 0.075inches, or may be about 0.070 inches. Further, in some examples, D₁ maybe between 0.010 inches and 0.075 inches, or may be between 0.025 inchesand 0.060 inches, or may be about 0.044 inches. In some examples, thedistance that a first radially extending portion 653A and secondradially extending portion 653B extends away from the surface of theshaft member 652 may be different. For example, a more proximal radiallyextending portion may extend radially outward from the shaft member 652a greater distance or a lesser distance than a more distal radiallyextending portion. In other examples (like those described above), thedistance that a first radially extending portion and a second radiallyextending portion extends away from the surface of the shaft member 652may be substantially equivalent.

It can be appreciated that the distance that radially extending portions653A/653B extend radially away from the surface of the shaft member 652may correspond to the force required to retract the tack member 694 froma body structure into which the tack 694 may be inserted. It can furtherbe appreciated that the shape, geometry, materials, etc. of the tackmember 694 may be tailored to impart specific withdrawal forces from abody structure into which the tack member 694 may be inserted.

Further, in one example tack member 94 may be the first portion ofdelivery system 40 that exists the distal end 48 of delivery sheath 42when the frame 46 and delivery shaft 44 are advanced out of the deliverysheath 42 upon deployment of the delivery system 40. In some instances,as the delivery sheath 42 is advanced through an insertion site toward atarget site, the frame 46 (to which implant 12 is attached) and astationary tack member 94 may be fully housed within the lumen 84 ofdelivery sheath 48. Additionally, as the delivery shaft 44 is advancedout the distal end 48 of the delivery sheath 44, the stationary tackmember 94 may be driven directly into an adjacent structure (e.g.,bone).

However, in other examples, frame member 46 and implant 12 may bepositioned within delivery sheath 42 (depicted as dashed line) as shownin FIG. 13A. FIG. 13A shows frame member 46 (with implant 12)substantially aligned longitudinally with delivery shaft 44 and tackmember 94. In this example, the distal portion 54 of frame 46 andimplant 12 may be located distal of tack member 94 within deliverysheath 42, and thus the first portion of delivery system 40 that exitsthe distal end 48 of delivery sheath 42 when the frame 46 and deliveryshaft 44 are advanced out of the delivery sheath 42 upon deployment ofthe delivery system 40.

In yet other examples, the frame member 146 and implant 112 may bepositioned within delivery sheath 42 as shown in FIG. 13B. Further, FIG.13B shows frame member 146 (and implant 112) substantially alignedlongitudinally with delivery shaft 44 and tack member 94. In thisexample, the distal portion of frame 146 and implant 112 may be locateddistal of tack member 94 within delivery sheath 42, and thus the firstportion of delivery system 140 that exits the distal end of deliverysheath 42 when the frame 146 and delivery shaft 44 are advanced out ofthe delivery sheath 42 upon deployment of the delivery system 40.

Additionally, FIG. 13C illustrates that implant 112 may be rolled up andpositioned between frame member 146 and the delivery sheath 42. Further,it can be appreciated that when positioned in delivery sheath 42 asillustrated in FIG. 13B, implant 112 may wrap around frame member 146with frame member 146 located radially inward of implant 112, andthereby extend along all or a portion of the inner surface of deliverysheath 42. Upon exiting the distal end of delivery sheath 42, implant112 may unwrap to a configuration illustrated in FIG. 10 and FIG. 11.

In other examples, tack member 94 may translate (e.g., slide, move,etc.) along a longitudinal axis within a lumen (not shown) of firstconnection member 90 of connection assembly 88. For example, FIG. 14shows example deployment system 40 positioned adjacent an example targetsite. FIG. 14 shows the proximal portion 52 of the frame 46 (along withimplant 12) positioned adjacent the humeral head 16. In this position,the distal portion 54 of the frame 46 is positioned adjacent the tendon24. FIG. 14 further illustrates that the tack member 94 has not beenadvanced and/or extended out of the first connection member 90 ofconnection assembly 88 and driven into the humeral head. Rather, thetack member 94 remains positioned within the connection assembly 88(e.g., positioned within first connection member 90). However, in someexamples contemplated herein, tack member 94 may be advanced out of thedistal portion of delivery shaft 44 and/or connection assembly 88. Inother words, the tack member 94 translates (e.g., slides, moves, etc.)relative to connection assembly 88 and advances away from the distal end50 of delivery shaft 44.

FIG. 15 illustrates tack member 94 being advanced out of the distalportion 50 of delivery shaft 44 after delivery shaft 44 (along withframe 46 and implant 12) have been maneuvered and/or positioned adjacentan example target site. In some examples, FIG. 15 may depict deliverysystem 40 (discussed with respect to FIGS. 7 and 8) after the tackmember 94 has been advanced out of the distal end 50 of the deliveryshaft 44 (e.g., advanced distally of first connection member 90) andinto the humeral head 16. As discussed above, tack member 94 may beadvanced out of the distal end 50 of delivery shaft 44 via theapplication of a force at the proximal end of the delivery system 40and/or actuation of an actuation mechanism to move tack member 94relative to first connection member 90. In some instances, a handlecomponent may be utilized to generate a force to advance tack member 94along a longitudinal axis of delivery shaft 44 and exit the distal end50 of delivery shaft 44 distal of first connection member 90.

FIG. 15A illustrates the anchoring mechanism of the example tack member394 (discussed above). As discussed with respect to FIG. 15, in someexamples the tack member 94 (of which tack member 394 shown in FIG. 15Ais a variation) may be anchored into the humeral head 16 of the humerus(a portion of which is shown in FIG. 15A). As shown in FIG. 15A, thehumeral head 16 may include a cortical shell 17 covering a layer of softbone 19. The cortical shell may be referred to as “hard” bone. FIG. 15Afurther illustrates that in some instances it may be desirable toadvance the tack member 394 through the layer of cortical bone such thatthe first radially enlarged portion 356A and/or the second radiallyenlarged portion 357A is positioned beneath the cortical bone layer. Inother words, the tack member 394 may be advanced into the humeral head16 such that the first radially enlarged portion 356A and/or the secondradially enlarged portion 357A is positioned within the layer of softbone, wherein the first radially enlarged portion 356A and/or the secondradially enlarged portion 357A provide resistance to being pulled backthrough the underside of the cortical bone layer. In instances in whichthe first radially enlarged portion 356A and/or the second radiallyenlarged portion 357A are made of a compressible material, the firstradially enlarged portion 356A and/or the second radially enlargedportion 357A may be compressed as the first radially enlarged portion356A and/or the second radially enlarged portion 357A are passed throughthe cortical shell 17. It can be appreciated that the amount ofresistance provided by the first radially enlarged portion 356A and/orthe second radially enlarged portion 357A may depend on the specificsize and geometry of the first radially enlarged portion 356A and/or thesecond radially enlarged portion 357A.

In some instances, once tack member 94 has been anchored into a targetsite (as described above), it may be desirable to remove the deliveryshaft 44 to make room for additional instruments to be advanced adjacentthe target site. FIG. 16 illustrates removing delivery shaft 44 from thetarget site (depicted by the arrow in FIG. 16) while the frame 46 andimplant 12 remain anchored to the humeral head 16 via the tack member94. As discussed above, delivery shaft 44 may be detached from frame 46via uncoupling (e.g., detaching) second connection member 92 from firstconnection member 90.

In some instances, it may be desirable to reengage delivery shaft 44after detaching second connection member 92 from first connection member90. For example, in some instances, the bone (e.g., humeral head) inwhich tack member 94 is initially inserted may be abnormally soft orhard, and therefore, may require additional force to either maintainplacement (e.g., if the bone is too soft) or to remove (e.g., if thebone is too hard). Therefore, a clinician may choose to reinsert andreengage shaft member 44 to frame 46 via re-coupling second connectionmember 92 to first connection member 90, such as after implant 12 hasbeen attached to a target site via one or more bone and/or tendonstaples, as described below. Alternatively, shaft member 44 may remainengaged to frame 46 while attaching implant 12 to a target site via oneor more bone and/or tendon staples, as described below. The clinicianmay then be able to apply additional force to frame 46 and/or tackmember 92 when attaching implant 12 to an example target site via one ormore bone and/or tendon staples.

As discussed above, delivery system 40 may include a tether 96 directlyor indirectly coupled to frame 46. It can be appreciated that tether 96may remain attached to frame 46 (e.g., via first connection member 90)and extend to a location exterior of the patient through insertion site(i.e., incision) with delivery shaft 44 detached from frame 46 andremoved from insertion site (i.e., incision) while additionalinstruments are advanced through the insertion site and to the targetsite. For example, FIG. 17 shows a medical instrument 98 (e.g., implantstapler) positioned adjacent the proximal end 52 of the frame 46 andimplant 12. As discussed above and shown in FIG. 17, tether 96 remainsattached to frame 46 (e.g., via first connection member 90) and ispositioned exterior of and alongside example medical instrument 98. Themedical instrument 98 may be used to attach implant 12 to treatmentsite, such as with one or more, or a plurality of staples and/orsutures.

As discussed above, in some instances, implant 12 may be affixed to atarget site after which the frame 46 may be detached (and removed) fromboth implant 12 and the target site. For example, in some instances,implant 12 may be attached to a target site via one or more bone and/ortendon staples. The staples may be applied to the target site via astapling instrument (e.g., medical instrument 98).

Further, in some instances, it may be beneficial to affix implant 12 tothe bone portion of the target site (e.g., humeral head 16) prior toaffixing the implant to the tendon portion 24 of the target site. Forexample, it may be beneficial for a clinician to orient and/or positionthe frame 46 and implant 12 in the location/arrangement shown in FIG. 17prior to affixing the implant to the target site. As shown in FIG. 17(and previously discussed) the implant is positioned such that theproximal portion 52 of the frame 46 and implant 12 are positionedadjacent the humeral head 16, while the distal portion 54 is positionedadjacent the tendon 24. Once the frame 46 and implant 12 have beenplaced appropriately, it may be desirable to utilize a staplinginstrument to first insert staples along the proximal portion 52 of theimplant (e.g., the portion of the implant 12 positioned adjacent thebone) and into bone, followed by insertion of staples along the sidesand distal portion of implant 12 and into tendon tissue.

It can be further appreciated that because the examples disclosed hereinallow for the removal of the delivery sheath 42 and delivery shaft 44prior to insertion of the stapling instrument, sufficient room exists tomanipulate the stapling instrument in order to accurately place thestaples along the proximal portion 52 of the implant adjacent thehumeral head 16.

Additionally, as discussed above, the tack member 94 may anchor theframe 46 and implant 12 in place (e.g., to the bone 16), therebyallowing a clinician to remove the delivery shaft 44 without fear thatthe frame/implant 46/12 combination will change position prior to theinsertion of staples into the implant 12.

Once the implant 12 has been sufficiently affixed to the target site,the clinician may detach the frame 46 from the implant 12 (within thebody) and remove it from the body via the insertion site. For example,FIG. 18 shows the detachment and removal of the frame 46 from theimplant 12 (within the body) after the implant has been affixed (e.g.,via staples) to the target site. In some instances, the clinician maydetach and remove frame 46 from the implant 12 and the body viaapplication of a withdrawal force to the frame 46. The withdrawal forcemade be applied via the tether 96. For example, a clinician may pull onthe tether 96 (the proximal end of which may be positioned outside ofthe body), thereby applying a withdrawal force to frame 46. Once thewithdrawal force reaches a threshold level (as discussed above), theframe 46 will detach from implant 12. Further withdrawal of the tether96 may be continued to pull frame 46 out of the body via the insertionsite.

It should be understood that this disclosure is, in many respects, onlyillustrative. Changes may be made in details, particularly in matters ofshape, size, and arrangement of steps without exceeding the scope of thedisclosure. This may include, to the extent that it is appropriate, theuse of any of the features of one example embodiment being used in otherembodiments. The disclosure's scope is, of course, defined in thelanguage in which the appended claims are expressed.

What is claimed is:
 1. An implant delivery system, the implant deliverysystem comprising: a delivery shaft including a proximal portion, adistal portion and a lumen extending there between; a frame detachablycoupled to the distal portion of the delivery shaft; a tack membercoupled to the frame; and a sheath having a lumen, wherein the deliveryshaft and the frame are slidably disposed within the lumen of thesheath; wherein the sheath constrains the frame in a contractedconfiguration within the lumen of the sheath.
 2. The implant deliverysystem of claim 1, further comprising a tether member coupled to aproximal portion of the tack member.
 3. The implant delivery system ofclaim 2, wherein the tether member extends within the lumen of thedelivery shaft.
 4. The implant delivery system of claim 1, wherein theframe includes a body portion and a plurality of attachment armsextending away from the body portion.
 5. The implant delivery system ofclaim 2, wherein the tack member extends through an aperture in the bodyportion of the frame.
 6. The implant delivery system of claim 5, whereina distal end portion of the tack member is configured to engage with abone.
 7. The implant delivery system of claim 6, wherein retraction ofthe tether member is designed to disengage the tack member from a bone.8. The implant delivery system of claim 7, wherein the distal endportion of the tack member includes a tapered region.
 9. The implantdelivery system of claim 2, wherein a proximal end portion of the tackmember includes a bore extending along a longitudinal axis of the tackmember.
 10. The implant delivery system of claim 9, wherein a distal endportion of the tether member is secured within the bore of the tackmember.
 11. The implant delivery system of claim 4, wherein theplurality of attachment arms are configured to be attached to animplant.
 12. The implant delivery system of claim 1, wherein the frameis configured to detach from the delivery shaft in vivo.
 13. The implantof claim 2, wherein the tether is directly coupled to the frame.
 14. Theimplant of claim 2, wherein the tether is indirectly coupled to theframe via a connection member.
 15. The implant delivery system of anyone of claim 14, wherein the frame further comprises a first apertureconfigured to couple with the connection member.
 16. An implant deliverysystem, the implant delivery system comprising: a delivery shaftincluding a proximal portion, a distal portion and a lumen extendingtherebetween; a frame detachably coupled to the distal portion of thedelivery shaft; a tack member coupled to the frame; a tether membercoupled to a proximal portion of the tack member; wherein the tethermember is indirectly coupled to the frame via a connection member; and asheath having a lumen, wherein the delivery shaft and the frame areslidably disposed within the lumen of the sheath; wherein the sheathconstrains the frame in a contracted configuration within the lumen ofthe sheath.
 17. The implant delivery system of claim 16, wherein thetether member extends within the lumen of the delivery shaft.
 18. Theimplant delivery system of claim 16, wherein the frame includes a bodyportion and a plurality of attachment arms extending away from the bodyportion.
 19. The implant delivery system of claim 18, wherein the tackmember extends through an aperture in the body portion of the frame. 20.The implant delivery system of claim 19, wherein a distal end portion ofthe tack member is configured to engage with a bone.
 21. The implantdelivery system of claim 20, wherein retraction of the tether member isdesigned to disengage the tack member from a bone.
 22. The implantdelivery system of claim 20, wherein the distal end portion of the tackmember includes a tapered region.
 23. The implant delivery system ofclaim 16, wherein a proximal end portion of the tack member includes abore extending along a longitudinal axis of the tack member.
 24. Theimplant delivery system of claim 23, wherein a distal end portion of thetether member is secured within the bore of the tack member.
 25. Theimplant delivery system of claim 18, wherein the plurality of attachmentarms are configured to be attached to an implant.
 26. The implantdelivery system of claim 16, wherein the frame is configured to detachfrom the delivery shaft in vivo.
 27. The implant delivery system ofclaim 16, wherein the frame further comprises a first apertureconfigured to couple with the connection member.
 28. The implantdelivery system of claim 16, wherein the connection member includes afirst profile and wherein the lumen of the delivery shaft includes asecond profile, and wherein the first profile is configured to mate withthe second profile.
 29. The implant delivery system of claim 28, whereinthe connection member engages with the distal portion of the deliveryshaft such that manipulation of the delivery shaft causes manipulationof the connection member, wherein the connection member is configured todisengage from the delivery shaft, and wherein the connection member isconfigured to remain engaged to the frame after disengaging from thedelivery shaft.
 30. The implant delivery system of claim 16, wherein thetack member is stationary with respect to the connection member.
 31. Theimplant delivery system of claim 16, wherein the tack member cantranslate with respect to the connection member.
 32. The implantdelivery system of claim 16, wherein the tack member includes a shafthaving a circumferential surface and one or more protrusions extendingradially away from the circumferential surface.
 33. The implant deliverysystem of claim 32, wherein the one or more protrusions are configuredto anchor the tack member beneath a layer of bone.
 34. The implantdelivery system of claim 32, wherein the one or more protrusions arespaced away from each other along the shaft.
 35. The implant deliverysystem of claim 16, wherein the tack member includes a shaft formed froma first material and one or more fixation members disposed along theshaft, wherein the one or more fixation members are formed from a secondmaterial different from the first material.
 36. The implant deliverysystem of claim 35, wherein the one or more fixation members extendradially away from a circumferential surface of the shaft.
 37. Theimplant delivery system of claim 16, wherein the tether member extendswithin the lumen of the delivery shaft while the delivery shaft isattached to the frame, and wherein the tether member remains connectedto the frame when the delivery shaft is detached from the frame.
 38. Theimplant delivery system of claim 16, wherein manipulation of thedelivery shaft relative to the sheath causes the frame to be advancedout of the lumen of the sheath such that the frame assumes an expandedconfiguration.
 39. The implant delivery system of claim 1, whereinmanipulation of the delivery shaft relative to the sheath causes theframe to be advanced out of the lumen of the sheath such that the frameassumes an expanded configuration.